A Guide to Perfecting Training Management for Medical Device Companies

Key Takeaway: Because the medical device industry is subject to compliance and regulations, companies must implement a robust training management plan for the benefit of internal employees and users of their products such as customers, partners, and distributors.

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Medical devices are classified as any apparatus, appliance, or material intended to be used by someone for a medical purpose. This can range from something as simple as a tongue depressor to complex devices such as surgical robots and MRI machines. Small or large, medical devices will be used by both the health practitioner as well as the patient themselves, so it’s paramount that proper education and training are given by manufacturers to the end-users for their safety and well-being. 

The medical device industry is booming. And, now more than ever, the safety and quality of medical products align with profitability. With an increasingly complex range of medical conditions, and the development of sophisticated treatments, comes a need for technology and devices to manage them. The global medical devices market is projected to grow from $495.46B in 2022 to $718.92B by 2029.

In Europe alone, there are more than 500,000 medical devices and equipment available for at-home and in-clinic use. That’s a staggering number! From the most basic in-mouth thermometer to a PET Scan machine at your local radiology clinic, proper training procedures must be put in place to maintain quality and safety standards.

So, what do medical device manufacturers need to know about regulations and compliance? And how can incorporating a sound training program for users improve quality management? 

Why are there regulations for medical devices?

Safety is the most important consideration in the medical device industry. Protecting healthcare providers (HCPs) and patients from injury or negative effects from their medical devices is of paramount importance. So, these devices must be designed, manufactured, and rolled out according to rigorous country-level and industry-level standards. Failure to comply with these regulations can result in fines, as well as legal or medical consequences, so there is no room for error.

For example, in 2018, US medical device company Medtronic had to recall over 1,000 MiniMed insulin pumps, used by people with diabetes to administer insulin. This is because there were cybersecurity concerns, potentially leaving diabetes patients vulnerable to hackers who could take control of the device’s controls and alter the insulin delivered, which could result in serious illness or death.

In 2017, Zimmer Biomet had to recall 33 implantable spinal fusion stimulators, used in spinal fusion surgery, as a routine monitoring procedure found high levels of potentially harmful chemicals in two different products. This could have resulted in serious medical consequences ranging from infections to death, meaning the products had to be removed from use.

Outside the manufacturing process, these medical device regulations also cover areas like advertising and labeling. This is to avoid misleading claims in the marketing of medical devices, meaning patients and HCPs know exactly what they’re getting and what they can expect from it. For instance, the Advertising Standards Authority (ASA) ruled that a medical device that claimed to treat mild to moderate Alzheimer’s could not be advertised as such as the evidence was not robust enough to make such a claim.

What is the role of regulatory compliance for medical devices?

The healthcare industry is subject to some of the strictest compliance regulations in the world and with good reason. When it comes to patient (and HCP) health, the stakes are high, and everyone must have the training and information they need to use their medical devices correctly. It can be as simple as knowing how to safely put on surgical gloves or as complex as installing a pacemaker correctly – no matter what the device may be, comprehensive, high-quality training is crucial. 

Put simply, medical device regulations are there to keep everyone safe and protected from everything ranging from needle stick injuries to serious medical complications or even death. Compliance regulations cover everything from the facilities used, to the personnel hired, to the devices themselves, to the rigorous testing processes laid out by various regulating bodies. For instance, are the manufacturing facilities and processes sterile? Are the manufacturing personnel themselves sufficiently trained to create a quality product? And does the end product comply with the relevant regulations for the region? 

Non-compliance with regulatory requirements can result in legal consequences, product recall orders, reputation damage, and even harm to healthcare providers. Therefore, regulatory compliance is essential to ensure patient safety, maintain public trust, and facilitate access to safe and effective medical devices. 

Laws regulating the design and manufacturing of medical devices

In the US, the FDA has established Quality Systems Regulations (QSR) addressing medical device design, validation, and manufacturing processes, as well as investigating complaints and surveilling device performance over time to maintain safety across the entire device lifecycle. 

The FDA also has an extensive list of how medical devices should be manufactured, stored, and shipped, as well as laws that signify their approval under specific conditions. These regulations cover factors such as manufacturing, sterilization, labeling, and quality control, ensuring that every single step of the process is closely monitored and adheres to the necessary medical device regulations.

In the EU, medical devices are subject to similarly stringent regulations. Once a medical device has passed its necessary assessments, it can be marked with a Conformité Européenne (CE), signifying that it has passed a strict audit and review process and has been deemed safe for use. There are also regulations on medical devices (Regulation (EU) 2017/745) and on in vitro diagnostic devices (Regulation (EU) 2017/746).

Regulatory compliance may involve harmonization efforts to align standards and regulations across different countries or regions. For example, the Medical Device Regulation (MDR) in Europe seeks to standardize requirements for medical devices across EU member states, ensuring consistency throughout the market and raising standards across the board.

Protocols like those found in the US and EU ensure that medical devices are safe, high quality, and subject to controlled monitoring, keeping both patients and medical professionals safe. 

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What are the certification requirements for medical devices?

Medical device manufacturers must meet several certifications to attain credibility for their devices and reassure distributors, vendors, and patients of their safety. Typically, these will be ISO (International Organization for Standardization) certifications, recognized worldwide. 

Some of the most common medical device certifications applying to manufacturers globally include:

  • ISO 13485 – Ensures quality management processes established by the medical device manufacturer are implemented and put in place throughout the entire product lifecycle, including service and delivery. These systems provide a framework for the design, development, manufacturing, and distribution processes to minimize risk and ensure sufficient documentation and quality control is in place. 
  • ISO 9001 – Demonstrates that medical devices and their manufacturers establish continual improvement in the design, development, and manufacturing of such devices before they hit the market. Using ISO 9001 helps ensure that patients and HCPs get consistent, high-quality products and services. 
  • ISO 14971 – Risk management controls used to determine the efficacy of the device being used for both the safety of the user and the patient. These can include design safety, protective measures against accidents caused by the device or with the device, and informational safety of using the device. 
  • Good Manufacturing Practices (GMP) – GMP helps ensure the quality, safety, purity, and strength of medical devices and products released to the public, and they are an interrelated set of practices based on existing laws followed by manufacturers. 
  • Quality Management System (QMS) – A QMS is a set of policies, processes, and procedures put in place by medical device manufacturers to ensure the safety and efficacy of their products. 

Other common ISO standards that are adopted by medical device manufacturers include: 

  • ISO 27001This focuses on cybersecurity standards, guiding for establishing, implementing, maintaining, and continually improving an information security management system to manage IT-related risk. ISO 27001 would be useful in situations such as the Medtronic insulin pump recall example mentioned above. 
  • ISO 45001This standard is about occupational health and safety and providing better, safer workplace conditions. This is especially important in the medical device and wider healthcare industry for keeping HCPs and their patients safe in high-risk work environments. 

Importance of training for medical device regulation and competency

Why is training so important in the world of medical device manufacturing? Given the stringent role of safety and efficacy in healthcare, medical device manufacturers are required to make sure that personnel who are involved in using or creating such devices are trained to the highest standards.

The goal of training in the world of medical devices is to establish competency. Within the device manufacturing setting, “competency” primarily means understanding the design process of the device and understanding how the device will be used, what purpose will it serve, what are the design elements, and what are the best safety protocols. After the device is completed and brought to the consumer in the healthcare market, competency becomes a matter of ensuring users know how to safely use the medical device product that is provided to them.

It is at the consumer end – the doctors, hospitals, and even patients – who tend to be the most critical part of ensuring competency for users. Because innovative medical equipment can be confusing to use, manufacturers must provide a comprehensive training course for their users so they can use the device in best practice.

The Scope of Training Management for Medical Device Manufacturers

Throughout the various stages of product development, diligent efforts are invested in creating a device that is both safe and effective. Comprehensive policies and procedures are established to govern every aspect, ranging from supplier sourcing to addressing defects. However, without adequately training the individuals responsible for implementation and maintenance, these policies and procedures remain mere words on paper.

The timing of training sessions is crucial. Whenever a mandatory document exists, a corresponding training record should accompany it. Rather than specifying training requirements for specific roles, regulations, and standards emphasize the importance of training individuals who are entrusted with performing specific tasks according to the relevant policies and procedures. This approach is particularly relevant for smaller organizations where employees often assume additional responsibilities beyond their core job titles or functional roles.

The notion of competence is frequently highlighted in the industry. Are your team members truly proficient in executing the essential aspects of their jobs? For instance, if they are responsible for supplier sourcing and management, do they possess the necessary skills to make well-informed decisions? Are they well-versed in the requirements for ongoing quality assurance?

Consider the team members who carry out validation activities. How will they determine if the device or component meets the prescribed standards or falls short? Do they understand the appropriate course of action if a failure occurs? Individuals must possess specific knowledge regarding the steps they should take in the event of any complications.

Managing quality control training and consumer training

Great! We’ve established that competent learning practices are best for those who work in medical device manufacturing (engineers, QA analysts, designers) and medical device users (healthcare workers). To ensure a proficient level of competency, the medical device company should provide regular training to both audiences. Courses on how to use the device are normally scheduled via a manual scheduling method. What is that exactly?

Manual training management methods

Most medical device companies manage training via a spreadsheet – or a collection of spreadsheets – that outlines the training course schedule. Within a single training schedule, a spreadsheet will likely contain the following  information:

  • Course name
  • Instructor/trainer
  • Meeting time(s)
  • Course duration
  • certificates or certifications to be awarded
  • Meeting place (in-person or online)
  • List of personnel attending the course(s)

Most L&D professionals in a medical device manufacturing company would see this as the standard or traditional way of getting learning scheduled for end-users and team members. The biggest benefit of using the manual training management method is that in the beginning, it’s easy to start and can be rolled out quickly.

The biggest drawback, however, is that spreadsheets don’t allow proper scale or efficiency for anyone involved. Some of the common headaches found between trainees, training managers, facilitators, and management normally include:

Trainees
  • Disorganized and mismanaged training can make the learning experience cumbersome and tedious.
  • Learners often find themselves not having the proper paperwork or documents needed to complete training in conjunction with the course.
  • Re-training and reskilling on medical device knowledge is often poorly managed to end-users’ current schedule.
Learning & Development (L&D)
  • Managing spreadsheets that contain hundreds of lines of information becomes difficult to handle even for the most seasoned training managers. On top of compliance paperwork, L&D professionals must also worry about whether their plan has the right instructor, resources, and attendees for hundreds of learners at a time.
  • Difficulty in measuring baseline and target learning goals for end-users.
  • Managing training feels like a bureaucracy from L&D to the learners as they must wrestle with compliance and QA checks for medical device usage.
Management Teams
  • Business and brand image risks face medical device manufacturers. If a medical device isn’t coupled with manufacturer-guided training and customer support, the result can be poor trust in the company.
  • Ensuring internal employees are trained properly but also fast and efficiently without the reliance on self-learning through onboarding documentation.
  • Inability to prove to stakeholders the quality that OEM-provided training can give to end users due to a lack of proper training metrics and analytics.

Whether training is meant to meet compliance and safety standards, onboard or reskill employees, or train healthcare professionals about how their latest products, manual training management is not a recommended method.

Manual-based training management for medical device companies is a recipe for disaster that no company should think twice about implementing due to the increased risk factors for output, brand awareness, and increased administrative duties.

So what exactly then becomes the solution to managing training for a medical device organization?

Utilizing automated training processes within Your Quality Management System (QMS)

For medical device organizations, training and training procedures must have the same quality as the medical devices produce: fast, efficient, and useful. 

While user training is an integral part of a company’s quality management system (QMS), it’s clear that medical device companies will fail to provide quality training for users and employees if relying on manual processes with spreadsheets. What’s the solution to manual processes for training management?

The utilization of a training management system (TMS).

Training management software (TMS) is an essential component of an already existing quality management system that most medical devices adhere to. To provide quality in both the product and product training, companies must have set processes on how the product’s design and information will be provided to stakeholders.

The addition of a TMS, like Training Orchestra, is aimed at supplementing the L&D processes of a medical device company. Instead of that messy “system” of spreadsheets used to manage course schedules, instructor rosters, and course certifications, the TMS replaces the manual components of scheduling and learning resource management. This way, there’s no confusion as to which resources are needed for instructor-led training or virtual instructor-led training for your next session or scrambling between tabs to ensure device subject matter experts are going into the right meeting room.

Advantages of using a Training Management System with LXP and LMS Platforms

While a Learning Management System (LMS) and/or Learning Experience Platform (LXP) can handle the on-demand element of training, such as e-learning modules, a resource repository, or a knowledge-sharing platform, how can these organizations manage the live element of training, whether that’s in person, online or hybrid? 

A Training Management System (TMS) is the perfect companion to an LMS and LXP, completing the technology stack by filling in the live training gap. With a TMS such as Training Orchestra, life sciences organizations are empowered to schedule, manage, and track instructor-led training (ILT) and virtual instructor-led training (vILT). 

Particularly useful for organizations dealing with medical devices is the Certification Management Portal, where training teams can keep track of ISO standardization and regulatory compliance adherence. For instance, some certifications may expire after a certain amount of time, so to save a training admin from having to manually keep track of expiry dates and send reminders, this all takes place automatically within the Certification Management Portal, making it much easier to manage the compliance training process. It also makes it easier to pull compliance data for audits, and training teams and managers can see at a glance who is behind on their ISO and compliance training to keep everyone on track. 

A comprehensive scheduling system is also crucial for managing the compliance training process. With Training Orchestra, the color-coded drag-and-drop interface makes it much easier for admins to schedule live training sessions for their personnel. In this scheduling system, they can quickly see which instructors are available, their areas of expertise, languages spoken, experience with ILT vs vILT, venues available, resources available, and more.  

On top of this, admins can manage their live training budget within the same platform. They can track their spending on instructors, rooms, equipment, and more, so they always know exactly how much they have left to spend, as well as identify which approach offers the best value for money and the best training outcomes. 

Getting started with medical device training and certification management

The world of ISO and regulatory compliance training can seem overwhelming for even the most seasoned medical device organization. Factor in a global audience, multiple products, and ever-changing rules and regulations, and suddenly it seems completely impossible to keep up! 

The good news is that Training Orchestra has over 20 years of experience in helping organizations in highly regulated sectors, such as life sciences, keep their people compliant and up to date with their industry’s unique regulations. 

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